Core Insights - Immunic, Inc. has completed enrollment for both Phase 3 ENSURE trials of vidofludimus calcium in patients with relapsing multiple sclerosis (RMS), with top-line data expected by the end of 2026 [1][3] - Additional data from the Phase 2 CALLIPER trial in progressive multiple sclerosis (PMS) supports the positive results previously released, highlighting the neuroprotective potential of vidofludimus calcium [1][4] Group 1: ENSURE Trials - The ENSURE program consists of two identical multicenter, randomized, double-blind Phase 3 trials aimed at evaluating the efficacy, safety, and tolerability of vidofludimus calcium versus placebo in RMS patients [2] - A total of 1,121 patients were enrolled in ENSURE-1 and 1,100 patients in ENSURE-2, with the primary endpoint being the time to first relapse over 72 weeks [2] - Secondary endpoints include time to confirmed disability worsening, volume of new T2 lesions, and MRI-based endpoints [2] Group 2: CALLIPER Trial Data - In the Phase 2 CALLIPER trial, vidofludimus calcium demonstrated a 24% reduction in the hazard ratio for 24-week confirmed disability worsening (24wCDW) compared to placebo [5] - The drug showed a 33% reduction in 24wCDW in primary progressive multiple sclerosis (PPMS) patients, a 19% reduction in non-active secondary progressive multiple sclerosis (naSPMS), and a 34% reduction in active secondary progressive multiple sclerosis (aSPMS) [5] - For patients without evidence of gadolinium-enhancing lesions at baseline, vidofludimus calcium reduced 24wCDW by 34% compared to placebo [5][6] Group 3: Vidofludimus Calcium Overview - Vidofludimus calcium is an investigational oral small molecule drug targeting chronic inflammatory and autoimmune diseases, currently in late-stage clinical trials for multiple sclerosis [7] - The drug acts as a selective immune modulator, activating the neuroprotective transcription factor Nurr1 and inhibiting dihydroorotate dehydrogenase (DHODH) to provide neuroprotective, anti-inflammatory, and anti-viral effects [7] - The drug has been tested in approximately 2,700 individuals, showing an attractive pharmacokinetic, safety, and tolerability profile [7]

Core Insights - TG Therapeutics presented data on BRIUMVI® (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS) at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting [1][2] - The company is optimistic about the ongoing data presentations throughout the year [2] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI approved for RMS treatment in the U.S., Europe, and the UK [23] - The company has a pipeline of investigational medicines in addition to BRIUMVI [23] Product Information - BRIUMVI is a monoclonal antibody targeting CD20-expressing B-cells, designed to deplete B-cells efficiently at low doses through glycoengineering [4] - It is indicated for adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease [5] Clinical Trials - The ULTIMATE I & II trials involved 1,094 RMS patients across 10 countries, comparing BRIUMVI to teriflunomide over 96 weeks [3] - The trials required patients to have experienced at least one relapse in the previous year or two relapses in the previous two years, with specific EDSS score criteria [3] Safety and Efficacy Data - Presentations at the CMSC included findings on the safety and tolerability of BRIUMVI, with a focus on infusion reactions and immunoglobulin levels [2][6] - The incidence of infusion reactions in BRIUMVI-treated patients was reported at 48%, with serious reactions occurring in 0.6% of patients [6][8] - The overall infection rate in BRIUMVI-treated patients was 56%, with serious infections at 5% [8] Market Context - Relapsing multiple sclerosis affects nearly 1 million people in the U.S., with 85% initially diagnosed with relapsing-remitting forms [22] - The global prevalence of MS is over 2.3 million [22]

Financial Data and Key Metrics Changes - U.S. net product revenue for Q1 2025 was approximately $119.7 million, reflecting a 137% increase year-over-year and a 16% increase sequentially from Q4 2024 [14][23] - GAAP net income for the quarter was approximately $5 million, or $0.03 per diluted share [24] - The company closed the quarter with $276 million in cash, cash equivalents, and investment securities, indicating a strong financial position [24] Business Line Data and Key Metrics Changes - BRIONVI U.S. net sales reached nearly $120 million in Q1 2025, exceeding expectations and demonstrating strong adoption by healthcare providers [5][14] - The first three months of 2025 marked the highest total new patient enrollment since the product launch, indicating accelerating demand [15] - Repeat prescriptions have now surpassed new prescriptions for the first time, signaling strong persistence trends [17] Market Data and Key Metrics Changes - The company is capturing approximately 25% of the IV segment market share, with continued growth in patient enrollments [29] - The hospital setting contributed approximately 60% of enrollments in March, the highest percentage to date [16] Company Strategy and Development Direction - The company aims to make BRIONVI the number one prescribed anti-CD20 therapy by focusing on a multi-phase launch strategy and enhancing the patient experience [8][12] - Plans include launching a direct-to-patient television commercial campaign and preparing for lifecycle innovations, including a subcutaneous formulation [19][21] - The company is also exploring new indications for BRIONVI, such as myasthenia gravis, while advancing its CAR T cell therapy pipeline [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth and potential for BRIONVI, citing strong demand and increasing prescriber confidence [20][21] - The company is monitoring potential tariffs but does not anticipate a material impact on gross margins or overall financial performance [26] Other Important Information - The ENHANCE clinical trial is evaluating strategies to simplify the patient experience, with positive feedback on a streamlined infusion regimen [9][10] - The company is on track to launch pivotal trials for both the simplified starting dose and the subcutaneous formulation of BREONVY [52][68] Q&A Session Summary Question: Competitive dynamics with OCREVUS and new patient share - Management noted strong patient enrollments and market share gains, with no impact from OCREVUS observed [29][30] Question: Update on gross to net trends and gross margin - No material change in gross to net was reported, and the pre-launch inventory reserve has been fully depleted, leading to consistent margins going forward [37][38] Question: Subcutaneous BREONVY pivotal trial details - The pivotal trial is expected to include two dosing regimens, with data anticipated later this year [41][42] Question: Physician feedback on the thirty-minute infusion - Positive feedback was received, indicating convenience for infusion centers and patients [49] Question: Phase III trial scale and profitability outlook - The company is not focused on profitability this year but aims to drive cash through the business while meeting revenue targets [54][55] Question: Update on North Carolina manufacturing plant - The North Carolina facility will take several years to reach commercial scale manufacturing [57][58] Question: Product adherence and trends - Persistence trends remain strong and above expectations, with no material changes in switch rates from OCREVUS [63][71]

Financial Performance - TG Therapeutics reported U.S. net revenue of $119.7 million for BRIUMVI in the first quarter of 2025, representing approximately 137% growth compared to the same period last year [5][9] - The company raised its full-year 2025 global net revenue target to approximately $575 million, up from a prior guidance of $540 million, and increased the U.S. net revenue target for BRIUMVI to approximately $560 million from $525 million [1][10] - The net income for the first quarter of 2025 was $5.1 million, compared to a net loss of $10.7 million for the same period in 2024 [9][41] Product Development and Commercialization - BRIUMVI is experiencing growing adoption among healthcare providers, with positive feedback from both patients and clinicians, reinforcing the company's goal of making BRIUMVI the number one prescribed anti-CD20 treatment [2][5] - The company is investing in innovation, including simplifying the BRIUMVI treatment regimen and advancing subcutaneous BRIUMVI [2][5] - BRIUMVI is now commercially available in additional countries in the European Union, United Kingdom, and Switzerland, expanding its market presence [5][10] Clinical Trials and Research - Five-year data from the ULTIMATE I & II Phase 3 clinical trials showed that 92% of patients were free from disability progression after five years of treatment with BRIUMVI [5] - Ongoing clinical trials include a Phase 1 trial evaluating subcutaneous BRIUMVI and another for azer-cel in patients with primary progressive multiple sclerosis [6][10] - The ENHANCE Phase 3b clinical trial demonstrated that a single 600 mg BRIUMVI infusion was well tolerated, and rapid 30-minute infusions were also well received by patients [5][10] Financial Guidance and Future Outlook - The company anticipates a second quarter 2025 U.S. net product revenue target of $135 million and expects total operating expenses for the full year 2025 to be approximately $300 million [10][41] - TG Therapeutics plans to commence pivotal programs for subcutaneous BRIUMVI and based on improved dosing regimens evaluated in the ENHANCE trial [10][41] - The company aims to continue enrollment in ongoing clinical trials for BRIUMVI in autoimmune diseases outside of multiple sclerosis [10][41]

CALLIPER Trial Results - Vidofludimus Calcium showed a 20% relative risk reduction of 24-week confirmed disability worsening (24wCDW) in the overall study population compared to placebo [38, 89] - In the primary progressive multiple sclerosis (PPMS) subgroup, Vidofludimus Calcium demonstrated an even more prominent 30% relative risk reduction in 24wCDW compared to placebo [38, 89] - Patients without gadolinium-enhancing (Gd+) lesions at baseline experienced a 29% reduction in disability worsening with Vidofludimus Calcium [41, 42, 90] - Vidofludimus Calcium resulted in a 5% improvement in the annualized rate of whole brain atrophy compared to placebo at 24 months [49] - Vidofludimus Calcium substantially reduced the annualized rate of thalamic brain volume loss by 20% compared to placebo at 24 months [49] - The volume of new/enlarging T2 lesions was 319% lower in the Vidofludimus Calcium group compared to the placebo group at month 24 [50, 52] Safety and Tolerability - The trial confirmed a favorable safety and tolerability profile for Vidofludimus Calcium, consistent with previous clinical trials, with similar frequencies of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in both treatment arms [56, 58, 90] Commercial Opportunity - The market for PPMS treatment is estimated to be over $6 billion, with a significant portion of diagnosed patients currently untreated [72, 74, 85] - Vidofludimus Calcium has a potential peak sales opportunity of $3-7 billion across relapsing MS (RMS), non-active secondary progressive MS (naSPMS), and PPMS indications [76, 80]

Core Insights - TG Therapeutics presented data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial for BRIUMVI at the ACTRIMS annual forum, highlighting its efficacy and safety in treating relapsing forms of multiple sclerosis (RMS) [1][2] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI approved for RMS treatment in the U.S. and Europe [27] Clinical Trial Details - The ULTIMATE I & II trials involved 1,094 patients across 10 countries, comparing BRIUMVI to teriflunomide over 96 weeks, with specific dosing regimens for both treatments [6] - The ENHANCE trial demonstrated a consistent safety profile for BRIUMVI, with over 80 patients receiving a 30-minute maintenance infusion [2][3] Presentation Highlights - An independent study presented by Dr. John Foley showed real-world data from over 160 patients treated with BRIUMVI, confirming its safety and tolerability [2][5] - Additional presentations included studies on disease activity trajectories and the design of a study evaluating Fc biology in multiple sclerosis [4][5] Product Information - BRIUMVI (ublituximab-xiiy) is a monoclonal antibody targeting CD20-expressing B-cells, designed for efficient B-cell depletion at low doses [8] - It is indicated for adults with RMS, including clinically isolated syndrome and active secondary progressive disease [9]

Core Viewpoint - Quantum BioPharma Ltd. has successfully completed a Phase 1 trial for its compound Lucid-MS, which showed no safety concerns and was well-tolerated in healthy participants, paving the way for future clinical development [1][3][4] Group 1: Trial Results - The final safety review committee found that Lucid-MS was well-tolerated with no serious adverse events reported during the trial [1] - The trial was a Phase 1, randomized, double-blind, placebo-controlled study evaluating the safety and pharmacokinetics of Lucid-21-302 in healthy adult participants [1] Group 2: Product Information - Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound aimed at treating multiple sclerosis (MS) by stabilizing the myelin sheath surrounding nerve fibers [2] - The compound is a patented New Chemical Entity (NCE) that has demonstrated the ability to prevent and reverse myelin degradation in preclinical models [5] Group 3: Future Development Plans - The completion of the Phase 1 trial allows the company to move forward with plans for a Phase 2 trial in MS patients [3][4] - The company aims to achieve drug approval and commercialization of Lucid-MS, focusing on arresting demyelination in MS [4] Group 4: Company Overview - Quantum BioPharma is dedicated to developing innovative solutions for neurodegenerative and metabolic disorders, with a focus on its lead compound, Lucid-MS [5] - The company retains a 25.71% ownership stake in Celly Nutrition, which is involved in the development of unbuzzd™, a product related to its portfolio [5]